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Methods, quality control and specimen management in an international multicentre investigation of type 1 diabetes: TEDDY

Author:
  • Kendra Vehik
  • Steven W. Fiske
  • Chad A. Logan
  • Daniel Agardh
  • Corrado Cilio
  • William Hagopian
  • Olli Simell
  • Merja Roivainen
  • Jin-Xiong She
  • Thomas Briese
  • Sami Oikarinen
  • Heikki Hyoty
  • Anette-G. Ziegler
  • Marian Rewers
  • Åke Lernmark
  • Beena Akolkar
  • Jeffrey P. Krischer
  • Brant R. Burkhardt
Publishing year: 2013
Language: English
Pages: 557-567
Publication/Series: Diabetes/Metabolism Research Reviews
Volume: 29
Issue: 7
Document type: Journal article
Publisher: John Wiley & Sons

Abstract english

BackgroundThe vast array and quantity of longitudinal samples collected in The Environmental Determinants of Diabetes in the Young study present a series of challenges in terms of quality control procedures and data validity. To address this, pilot studies have been conducted to standardize and enhance both biospecimen collection and sample obtainment in terms of autoantibody collection, stool sample preservation, RNA, biomarker stability, metabolic biomarkers and T-cell viability. Research Design and MethodsThe Environmental Determinants of Diabetes in the Young is a multicentre, international prospective study (n=8677) designed to identify environmental triggers of type 1 diabetes (T1D) in genetically at-risk children from ages 3months until 15years. The study is conducted through six primary clinical centres located in four countries. ResultsAs of May 2012, over three million biological samples and 250 million total data points have been collected, which will be analysed to assess autoimmunity status, presence of inflammatory biomarkers, genetic factors, exposure to infectious agents, dietary biomarkers and other potentially important environmental exposures in relation to autoimmunity and progression to T1D. ConclusionsDetailed procedures were utilized to standardize both data harmonization and management when handling a large quantity of longitudinal samples obtained from multiple locations. In addition, a description of the available specimens is provided that serve as an invaluable repository for the elucidation of determinants in T1D focusing on autoantibody concordance and harmonization, transglutaminase autoantibody, inflammatory biomarkers (T-cells), genetic proficiency testing, RNA lab internal quality control testing, infectious agents (monitoring cross-contamination, virus preservation and nasal swab collection validity) and HbA(1c) testing. Copyright (c) 2013 John Wiley & Sons, Ltd.

Keywords

  • Endocrinology and Diabetes
  • quality control
  • data integrity
  • stool sample preservation
  • RNA
  • biomarker stability
  • metabolic biomarkers
  • T-cell viability

Other

Published
  • Diabetes and Celiac Unit
  • Diabetes - Cellular Autoimmunity
  • ISSN: 1520-7552
E-mail: ake [dot] lernmark [at] med [dot] lu [dot] se

Principal investigator

Diabetes and Celiac Unit

+46 40 39 19 01

+46 70 616 47 79

60:11:015

Jan Waldenströms gata 35, Malmö

33

Lund University Diabetes Centre, CRC, SUS Malmö, Jan Waldenströms gata 35, House 91:12. SE-214 28 Malmö. Telephone: +46 40 39 10 00